Studies of a new treatment strategy for colorectal cancer using a therapeutic cancer vaccine technology have begun enrolling patients at several trial sites around the United States and Canada. The trial will enroll up to 90 patients with metastatic colorectal cancer who have not yet received treatment with standard chemotherapy, according to Aventis Pasteur Limited of Toronto, Canada, the study sponsor.
"The goal of the study is to determine if the vaccine, called ALVAC-CEA/B7.1, can activate the body’s own immune system to eliminate cancer cells that may not be eliminated with traditional treatment of metastatic colorectal cancer using the standard, first-line chemotherapy regimen," said Dr. Neil Berinstein, assistant vice president, clinical oncology, and program director, cancer, Aventis Pasteur. "We will be looking to see if the vaccine, combined with chemotherapy, allows a better outcome for patients than chemotherapy alone," he added.
Study Design
The multicenter, pilot phase II trial is designed to assess safety and immunologic activity, and will randomly assign patients to one of three treatment groups. One group will be vaccinated with ALVAC-CEA/B7.1 before beginning standard chemotherapy (with irinotecan(Drug information on irinotecan) [CPT-11, Camptosar], fluorouracil(Drug information on fluorouracil) [5-FU], and leucovorin) and will receive additional, concurrent doses of the vaccine with the chemotherapy. Another group will receive the same regimen described above plus doses of tetanus toxoid to determine whether this additional compound further enhances the immune response. The third group will receive standard chemotherapy; patients in this group who achieve complete or partial responses will have the option of receiving the ALVAC-CEA/B7.1 vaccine upon completion of the chemotherapy.
Treatment will require approximately 28 to 31 weeks, depending on which group patients are assigned to and how well they tolerate the chemotherapy regimen. Patients will be evaluated routinely for local and systemic adverse events immediately following treatment and at each follow-up visit. Immune response and efficacy measures for objective response and response duration will also be assessed at several predesignated points during treatment and at the end of the study.
Clinical trial sites have been established in New York; Washington, DC; Philadelphia; Los Angeles; Birmingham, Ala; Chicago; Dunmore, Pa; Vancouver, BC; and Ottawa. For more information about specific study locations and eligibility contact Aventis Pasteur Limited in Toronto at 1-866/455-0349.
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